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May 26, 2020
by Michael Mezher

Recon: Sanofi to sell $13B stake in Regeneron; Merck to buy vaccine maker Themis Bioscience

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Regeneron to buy back $5 billion stake held by Sanofi (Reuters) (Financial Times)
  • Merck to buy Austrian vaccine maker as it jumps into COVID-19 race (Reuters) (STAT)
  • FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on Covid-19 vaccine project (STAT)
  • Evofem's gel first non-hormonal contraceptive to get approval in over 30 years (Reuters)
  • NIH trial: Gilead's drug works best in COVID patients on oxygen (Reuters) (NYTimes) (NEJM)
  • Russian ventilators reached US states without FDA oversight (Reuters)
  • Novavax launches its first coronavirus vaccine test on humans (Reuters)
  • US plans massive coronavirus vaccine testing effort to meet year-end deadline (Reuters)
  • US is ahead of China in vaccine race, former FDA chief says (Politico)
  • Uncertain Results in Study of Convalescent Serum for Covid-19 (NYTimes) (Reuters)
  • How Upbeat Vaccine News Fueled a Stock Surge, and an Uproar (NYTimes)
  • Fears of coronavirus second wave prompt flu push at US pharmacies, drugmakers (Reuters)
In Focus: International
  • WHO pauses trial of hydroxychloroquine in COVID-19 patients due to safety concerns (Reuters)
  • Fujifilm COVID-19 drug research spills into June, dashing hopes of quick approval (Reuters)
  • Lilly, Junshi Biosciences plan to start human trials of COVID-19 antibody in second quarter (Reuters)
  • Oxford University Covid-19 vaccine trial has 50 per cent chance of 'no result' (The Telegraph)
  • Big pharma rejected EU plan to fast-track vaccines in 2017 (The Guardian)
  • How one Indian company could be world's door to a COVID-19 vaccine (Reuters)
  • CanSino coronavirus vaccine appears safe in first human trial (Reuters) (NYTimes)
  • First signs if a COVID-19 vaccine works possible in autumn: GAVI (Reuters)
  • Global fundraising for COVID-19 vaccine, drugs exceeds $10 billion, EU says (Reuters)
  • Disruption to global immunization system could delay COVID-19 vaccinations (Reuters)
  • Cuba credits two drugs with slashing coronavirus death toll (Reuters)
  • India's Glenmark to study potential COVID-19 drug combination (Reuters)
  • Healthineers ready to boost antibody test production to 50 million per month (Reuters)
Coronavirus Pandemic
  • Trump imposes travel restrictions on Brazil (The Hill)
  • EU frees up export of coronavirus protection equipment (Reuters)
  • South America a new COVID epicenter, Africa reaches 100,000 cases (Reuters)
  • WHO fears 'silent' virus epidemic unless Africa prioritizes testing (Reuters)
  • 'I'm looking for the truth': States face criticism for COVID-19 data cover-ups (NBC)
  • Fear of Covid Leads Other Patients to Decline Critical Treatment (NYTimes)
  • ‘This Is Not the Hunger Games’: National Testing Strategy Draws Concerns (NYTimes)
  • Cipla and Hetero seek clinical trial waiver for Remdesivir (Economic Times)
Pharma & Biotech
  • PDUFA Renewal Negotiations: What Does Industry Want Now? (Pink Sheet)
  • Pharma panics as Washington pushes to bring drug manufacturing back to the U.S. (STAT)
  • Argenx antibody drug improves symptoms in patients with myasthenia gravis (STAT)
  • Cancer cell therapies: the clinical trial landscape (Nature)
  • Tufts team repairs brain defects in frogs with 'bioelectric' drugs (Fierce)
  • Stéphane Bancel’s audacity pays off for Moderna (Financial Times)
  • ‘One thing cancer patients don’t generally have is time’: New cancer research leader brings urgency to Sanofi (STAT)
  • China Tightens Clinical Study Grip In Sweeping Biosecurity Law Proposal (Pink Sheet)
  • A Hidden Origin Story of the CBD Craze (NYTimes)
  • Sanofi: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis (Press)
  • Takeda's Alunbrig wins lung cancer approval; Atara offers another positive MS drug update (Endpoints)
  • PhII Alzheimer's data looming, Shionogi spending up to $500M on a buyout involving one of the toughest bets in biotech (Endpoints)
  • Alnylam nabs speedy review, setting up 3rd possible approval in 3 years (Endpoints)
  • As biotech IPOs sizzle on virtual Wall Street, 3 new players roll the dice on megamoney gambles topping $325M (Endpoints)
  • Ex-Axovant crew at Arvelle ups Series A haul, deploying $200M-plus to commercialize epilepsy drug in Europe (Endpoints)
  • Monthly statistics report: April 2020 (EMA)
  • Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens (FDA)
  • Boehringer Ingelheim and Lilly to collaborate with Duke Clinical Research Institute on a pragmatic trial examining Jardiance's® effects following an acute myocardial infarction (Press)
Medtech
  • Tech companies target temperature-monitoring patches for COVID-19 (Reuters)
  • Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic's Q4 (MedtechDive)
  • ResMed, Medtronic embrace remote tech amid COVID-19, say it's here to stay (MedtechDive)
  • Medtechs eye key role of ASCs in return of elective care (MedtechDive)
  • FDA clears 4D Medical’s lung imaging technology (MassDevice)
Government & Regulatory
  • How H.R. 6800 Might Impact the FDA (Alliance for a Stronger FDA)
  • US lawmakers unveil bold $100 billion plan to remake NSF (Science)
  • They redesigned PubMed, a beloved website. It hasn’t gone over well (Science)
  • Notice: Expansion of the medical device Regulatory Enrolment Process (REP) pilot and the scope for transactions sent via the Common Electronic Submissions Gateway (CESG) (Health Canada)
  • Pfizer, Ranbaxy Sued Over Delay Of Generic Lipitor (Law360)
  • Amerisource Hid 'Pillbillies' Email In Opioid MDL, Attys Say (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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